A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-08-20

Summary

This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic therapy.

Approximately 184 subjects with moderate to severe AD are planned to be randomized in a 1: 1: 1: 1 ratio to SIM0278 low dose, SIM0278 medium dose, SIM0278 high dose, or placebo. Subjects were stratified at randomization by baseline disease severity (moderate \[IGA = 3\] VS severe \[IGA = 4\]).

The study consisted of 4 phases: screening, double-blind induction, open-label maintenance, and safety follow-up.

• Phase: PHASE2

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.